Impax confirms patent challenge for generic Concerta

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

Impax Labs on Tuesday confirmed that Alza Corp., a subsidiary of Johnson & Johson, filed a patent infringement suit against Impax in connection with Concerta (methylphenidate hydrochloride) extended-release 54-mg tablets. Impax filed its abbreviated new drug application for a generic version of Concerta with the Food and Drug Administration in November 2002, and submitted Paragraph IV patent certifications in connection with two patents that were listed in the FDA’s Orange Book in 2005.

Impax said its generic Concerta products are part of its strategic alliance agreement with Teva Pharmaceuticals. Once the ANDA is approved by the FDA, Teva will commercialize the products, the drug maker said.

U.S. sales of Concerta in the 54-mg strength approximately were $365 million for the 12 months ended Sept. 30, according to Wolters Kluwer.

The company acquired Roselle (levonorgestrel and ethinylestradiol) and Optinor (levonorgestrel). ICON developed both drugs under a partnership with an unnamed generic drug manufacturer.

“This partnership with WomenCare Global is a significant step forward in expanding access to quality-assured generic hormonal contraceptives at competitive prices,” ICON general manager David Smith said in a statement.

Impax challenges Abbott’s Simcor patent

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

Impax’s application contained a paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that the patent covering Simcor is invalid or unenforceable, or that Impax’s version won’t infringe upon it. Abbott responded last Wednesday by filing a patent infringement suit against Impax in the U.S. District Court for the District of Delaware.

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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